DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia (DISPLAY)

Danish Dementia Research Centre

Status

Active, not recruiting

Conditions

Alzheimer Disease

Mild Cognitive Impairment

Dementia With Lewy Bodies

Treatments

Diagnostic Test: Motor examination

Diagnostic Test: Cognitive test

Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC)

Study type

Observational

Funder types

NETWORK

Other

Identifiers

NCT05768425

H-22046053

Details and patient eligibility

About

This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.

Full description

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.

DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. A novel technique for the measurement of misfolded alpha-synuclein (aSyn) is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process.

Objective: Determining which biospecimen alone or in conjunction with other biospecimens can most accurately discriminate patients with DLB from Alzheimer's disease (AD) assessed by RT-QuIC for aSyn.

Design: Cross-sectional case-control study of the diagnostic accuracy of pathological alpha-synuclein assessed by RT-QuIC in different biospecimens (CSF, skin, olfactory mucosa, saliva, feces, and urine) from patients with DLB versus AD.

Patients will also be scored with tests for cognitive function, dysautonomia, and movement disorders.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for healthy controls (HC):

Age 18 - 40 years of age
Able to cooperate as evaluated by the primary investigator (PI)
Able to give informed consent

Exclusion criteria

Signs of neurological/psychiatric conditions
Known genetic neurodegenerative disease in close family

Inclusion criteria for patients with Dementia with Lewy Bodies (DLB):

Probable DLB (McKeith et al., 2017) or MCI-LB (McKeith et al., 2020)
Age > 50 years of age
Able to give informed consent
Able to cooperate as evaluated by the PI
MCI, mild or moderate dementia, and MMSE > 18

Exclusion criteria for patients with DLB:

Patients not able to give informed consent.
Current alcohol or drug abuse
Terminal illness
Diagnosed with major neurological/psychiatric conditions other than DLB.

Inclusion criteria for controls (patients with Alzheimer's disease (AD)):

Probable AD (McKhann et al., 2011) or MCI-AD (Albert et al., 2011)
Age > 50 years of age
Able to give informed consent
Able to cooperate as evaluated by the PI
MCI, mild or moderate dementia, and MMSE > 18

Exclusion criteria for controls (patients with AD):

Patients not able to give consent.
Current alcohol or drug abuse
Terminal illness
Diagnosed with major neurological/psychiatric conditions other than AD.

Trial design

55 participants in 3 patient groups

Dementia with Lewy Bodies (DLB)

Description:

Mild cognitive impairment (MCI) to moderate dementia with probable DLB No other severe neurological or psychiatric diseases. No alcohol or drug abuse.

Treatment:

Diagnostic Test: Cognitive test

Diagnostic Test: Motor examination

Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC)

Alzheimers disease (AD)

Description:

MCI to moderate dementia with probable AD. No other severe neurological or psychiatric diseases. No alcohol or drug abuse.

Treatment:

Diagnostic Test: Cognitive test

Diagnostic Test: Motor examination

Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC)

Healthy Controls (HC)